Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000435-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Participants will receive tocilizumab intravenous (IV) infusion at a dose of 12 milligrams per kilogram (mg/kg) every two weeks (Q2W) during main evaluation period of 12 weeks (a total of 6 infusions including one at baseline visit). Participants will have the option to be treated in an optional extension period after completion of main evaluation period. In optional extension period, participants will receive tocilizumab 12 mg/kg IV infusion Q2W from Week 12 until the participant reaches 2 years of age or has been treated for one year from baseline, whichever is longer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab will be administered as indicated in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of Tocilizumab | Pharmacokinetic profile of tocilizumab is evaluated in terms of model predicted Cmax at steady state. Pharmacokinetic-evaluable population includes all participants who provided at least one serum pharmacokinetic sample with valid concentration data. | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) |
| Minimum Serum Concentration (Cmin) of Tocilizumab | Pharmacokinetic profile of tocilizumab is evaluated in terms of observed Cmin at day 85. Pharmacokinetic-evaluable population. | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) |
| Model predicted Area Under the Serum Concentration-Time Curve from Time Zero to End of Dosing (AUCtau) of Tocilizumab | AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval (2 weeks). Pharmacokinetic-evaluable population. | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs | Baseline up to end of the study (up to approximately 60 weeks) |
Not provided
Inclusion Criteria:
Fulfils international league of associations for rheumatology (ILAR) classification criteria for sJIA
Duration of sJIA symptoms lasting for at least 1 months subsequent to diagnosis of sJIA
Presence of active disease as determined by the presence of:
Not currently receiving corticosteroids (CS) or if taking oral CS like prednisone or equivalent, the dose should be less than or equal to (<=) 1 milligram per kilogram per day (mg/kg/day) and the dose has remained stable for at least 2 weeks prior to baseline
Not currently receiving methotrexate (MTX) or if taking MTX (together with either folic acid or folinic acid according to local standard-of-care), the dose has remained stable or has been discontinued for at least 4 weeks prior to baseline
Not currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) or if taking NSAID, the dose has remained stable or has been discontinued for at least 2 weeks prior to baseline
If the participants has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to the baseline visit and are not permitted during the study:
History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and CS
Exclusion Criteria:
General Exclusion Criteria:
General Safety Exclusion Criteria:
Excluded Previous or Concomitant Therapy:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center; Pediatric Rheumatology | Washington D.C. | District of Columbia | 20010-2970 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31438986 | Derived | Mallalieu NL, Wimalasundera S, Hsu JC, Douglass W, Wells C, Penades IC, Cuttica R, Huppertz HI, Joos R, Kimura Y, Milojevic D, Rosenkranz M, Schikler K, Constantin T, Wouters C. Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial. Pediatr Rheumatol Online J. 2019 Aug 22;17(1):57. doi: 10.1186/s12969-019-0364-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The University of Chicago;Department of Pediatrics |
| Chicago |
| Illinois |
| 60649 |
| United States |
| University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
| The Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Children's Hospital Boston Pediatric Medicine | Boston | Massachusetts | 02115 | United States |
| Children's Speciality Center of Nevada | Las Vegas | Nevada | 89109 | United States |
| Hackensack University Medical Center; Pediatric Rheumatology | Hackensack | New Jersey | 07601 | United States |
| Cincinnati Children'S Hospital Medical Center; Division of Rheumatology | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital Of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Hospital Gral de NiƱos Pedro Elizalde | Buenos Aires | 1270 | Argentina |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| McGill University; Montreal Children's Hospital; Inflammatory, Autoimmune & Bone | Montreal | Quebec | H4A 3J1 | Canada |
| Klinik Bremen-Mitte; Prof. Hess-Kinderklinik | Bremen | 28177 | Germany |
| Semmelweis University; 2nd Department of Paediatrics | Budapest | 1094 | Hungary |
| Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci | Lodz | 91-738 | Poland |
| Uniwersytecki Szpital Dzieciecy w Lublinie; Oddzial Pediatrii, Chorob Pluc i Reumatologii | Lublin | 20-093 | Poland |
| Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided